Putting patients first: Unchecked step therapy puts PBM profits ahead of patient care

This is the second in a series of Bio.News articles looking at the need for pharmacy benefit manager reform through the lens of the patient. Middlemen too often act in ways that pad their bottom line, but this is not simply a narrative about how money is diverted into PBM coffers. Examining the larger story about the ways that patients are left vulnerable is critical in understanding why changes are required.

Part of the business model of PBMs revolves around saving money by making it harder to receive care. One of the ways that PBMs accomplish this is by requiring patients and doctors to prove that certain medicines have failed the patient before other treatments are tried.

This practice, known as “step therapy” or “fail first,” tries to displace a provider’s clinical judgment in favor of the medicine selected by the PBM, which is often driven by the PBM’s narrow financial interest.

This harms patients.

• Research published in Health Affairs compared PBM step therapy requirements to the clinical guidelines published by physician organizations. It found that across 10 different therapeutic areas, fail-first policies were more stringent than professional guidelines more than half the time. In the case of psoriasis, 99.4% of step therapy policies couldn’t be reconciled with guidelines.
• This leads to worse outcomes for patients. One study in rheumatoid arthritis found that patients exposed to step therapy did 19% worse than patients whose choices weren’t constricted.

These patient-level impacts—impacts that have the potential to cause needless suffering among patients—explain why both patient allies and members of Congress have expressed an interest in addressing step therapy abuses:

• A consortium that includes the National Organization for Rare Disorders, the American Diabetes Association, and Susan G. Komen has called on senators and representatives to pass PBM reform that “would ensure that employer-sponsored health plans offer a timely and medically reasonable step therapy exceptions process.”
• Such legislation has already passed the Senate Health, Education, Labor, and Pensions Committee, with language calling for “a clear, prompt, and transparent process … to request an exception to such medication step therapy protocol.” That approach won praise from patient advocates.

BIO’s View: PBMs claim they are seeking cost savings in their utilization management decisions, but such efforts cannot run contrary to professional guidelines and risk patient outcomes. Those battling illness should never be railroaded into inefficient treatments or delays in receiving the care they need. Such considerations are a natural extension of other PBM reform efforts and should be considered in any broad PBM legislation.